Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
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- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT05620095
- Record updated
- 25 March 2026
- Original description
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).Read full original descriptionShow less
Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).
Inclusion: Rutherford grade 4-6; Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up; Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries >20 mm. Lesions should not extend beyond the ankle joint; Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow; At least one of the infrapopliteal arteries received a drug-coated balloon; For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%; In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention; Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time; Life expectancy> 24 months.
Exclusion: Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment; Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc; Patients with Berg's disease; Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia; Blood flow was not successfully reestablished; Pregnant and lactating women.